Affirmative
From 15 verified experts:
15 answered Likely or higher
Robert Carnahan has answered Near Certain
An expert from Vanderbilt University Medical Center in Immunology, Infectious diseases, Virology
The size, thoroughness, and complexity of the clinical trials conducted for the current COVID-19 vaccines were no different than traditional clinical trials. These are as safe as vaccines and interventions developed on much slower timelines. In either case, given the complexity and diversity of the human system, one can never guarantee freedom from a small number of adverse events. The scale of the trials should give us confidence that these will be small in number. In fact, we are now seeing a very small number of allergic reactions to the Pfizer/BioNTech vaccine. As no trial can accommodate every possible variable of the human body, this is not surprising. What is encouraging is these allergic events are infrequent and readily treatable. The speed to COVID19 vaccine release was assisted by numerous factors, that do not compromise safety. One, all of the vaccines at the forefront were manufactured "at risk". This means that they were being produced before the clinical trials were even completed. This would never happen in a normal situation. Many of these costs were supported by various government organizations around the globe. Therefore, the instant that emergency approval was secured, distribution could begin. Second, vaccine developers were rapidly analyzing data as it emerged and communicating this in real-time to various regulatory agencies. There are often gaps of months to years between the various phases of clinical trials due to these activities alone. Third, recruitment to clinical trials is often a slow and laborious process. There have to be people "at-risk" for the disease in many different demographic and health categories. Due to the immense scope of the pandemic, finding sufficient and appropriate volunteers was rapid. Relatedly, the rate of infection spread has to be sufficient to show meaningful difference between the vaccinated and control (unvaccinated) groups. The massive spread of the SARS-CoV-2 virus meant that showing a difference between these groups also happened rapidly. Lastly, necessity is the mother of invention. The rapid clinical trials, equal in quality to much longer trials, were possible because there was a convergence of many things: decades of prior research on coronaviruses, immense need, dedicated scientists, committed industry and academic organizations, highly responsive regulatory agencies, and public support for the effort. Though there have been many suboptimal actions, or lack of actions, to this pandemic, the efficacious development of medical treatments (vaccines, drugs, therapeutic antibodies, clinical approaches, etc.) is, collectively, one of the greatest achievements of public health and science in history. The release of these safe and effective vaccines is a marvel of human achievement, and a shining example of what can be achieved when many organizations and sectors work together.
Disclosure
Dr. Carnahan has been involved in the development of numerous SARS-CoV-2 therapeutic antibodies but is not directly involved in the development of SARS-CoV-2 vaccines.
Answered over 4 years ago
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